One Step (UDI GEFOB-602a-2T)
Manufactured by Healgen Scientific Limited Liability Company
Device Regulatory Overview
The One Step (Model/Catalog Number: GEFOB-602a-2T) is a medical device manufactured by Healgen Scientific Limited Liability Company. This product is indexed under FDA Product Code / Category Classification KHE within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- GEFOB-602a-2T
- Product Code / EMDN
- KHE
- Device Name
- One Step Second Generation FOB Rapid Test Cassette
- Database Sync Date
- 2026-08-09 09:05:25
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of One Step?
The registered manufacturer of record for One Step is Healgen Scientific Limited Liability Company.
What is the Primary UDI-DI identifier for One Step?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is GEFOB-602a-2T.
What classification code is assigned to this device?
This device is registered under product classification code KHE.
Similar Classification Devices (KHE)
Other Devices by Healgen Scientific Limited Liability Company
Programmatic Export
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